Body part fixation device with pitch and/or roll adjustment

ABSTRACT

A structure includes a base comprising a first ramp and an opposing, second ramp. The structure further includes a shell frame having an inner surface configured to a shape of a body part and an outer convex surface, wherein the outer convex surface of the shell frame rides upon, and moves relative to, upper surfaces of the first ramp and the second ramp to enable a pitch of the shell frame to be adjusted relative to the base.

CROSS-REFERENCE TO RELATED APPLICATION

The present application is a continuation-in-part (CIP) of U.S.application Ser. No. 15/859,993 (Attorney Docket No. 0080-1101),entitled “Body Part Fixation Device With Pitch and/or Roll Adjustment”and filed Jan. 2, 2018, which claims priority to U.S. ProvisionalApplication No. 62/460,389, filed Feb. 17, 2017, the disclosures ofwhich are incorporated by reference herein in their entireties.

BACKGROUND

Certain types of medical treatments require that a portion of a humanbody be held in a same position to facilitate performance of the medicaltreatment upon that portion of the body. For example, when brain cancerpatients undergo radiation treatment, their heads must be maintained ina precise, repeatable location for the treatment such that theunderlying position of the brain tumor is fixed in space for theduration of the radiation treatment or treatments. Various differenttechniques have been used in the field of radiation oncology for holdingbody parts in a fixed position.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A-1F depict views of an exemplary embodiment in which a body partimmobilization device is configured to immobilize a head of a patient;

FIGS. 2A-2C depict further details of the pitch adjustment mechanism,and shell frame to support base interface components involved in pitchadjustment of the shell frame, of the immobilization device of FIG. 1A;

FIGS. 3A-3D depict four different views of the support base of FIG. 1B,including a top view in FIG. 3A, a side view in FIG. 3B, a rear view inFIG. 3C, and a front view in FIG. 3D;

FIGS. 4A-4D depict four different views of the shell frame of FIG. 1A,including a top view in FIG. 4A, a side view in FIG. 4B, a rear view inFIG. 4C, and a front view in FIG. 4D;

FIG. 4E depicts further exemplary details of the flange of the shellframe of FIG. 1A;

FIGS. 5A-5E depict details of an exemplary embodiment of the pitchadjustment mechanism of FIG. 2A;

FIGS. 6A-6E depict details of an additional exemplary embodiment inwhich the pitch adjustment mechanism further includes a pitch adjustmentwheel that permits a precise, calibrated adjustment of the pitch ofshell frame relative to the support base;

FIG. 7 illustrates another exemplary embodiment of a body partimmobilization device that includes, in addition to a pitch adjustmentmechanism, a roll adjustment mechanism;

FIG. 8A depicts an exploded three-dimensional view of the body partimmobilization device of FIG. 7;

FIG. 8B is a three-dimensional view of the components of the body partimmobilization device of FIG. 7 that are involved in adjustment of thepitch of the shell frame carriage and the shell frame;

FIG. 8C is a three-dimensional view of the components of the body partimmobilization device of FIG. 7 that are involved in adjustment of theroll of the shell frame;

FIGS. 9A-9D depict four different views of the shell frame of the bodypart immobilization device of FIG. 7;

FIGS. 10A and 10B depict the support base and the shell frame carriageof the device of FIG. 7 in a horizontal position prior to any adjustmentbeing applied to change the pitch of the shell frame carriage relativeto the support base;

FIGS. 11A and 11B depict adjustment of the pitch of the shell framecarriage and the shell frame of the device of FIG. 7;

FIG. 12 depicts the shell frame, the shell frame carriage, and thesupport base of the device of FIG. 7 in a horizontal position prior toany roll adjustment being applied to change the roll of the shell framerelative to the shell frame carriage and the support base;

FIGS. 13A and 13B depict adjustment of the roll of the shell framerelative to the shell frame carriage and the support base of the deviceof FIG. 7;

FIG. 14 depicts another exemplary embodiment in which a body partimmobilization device, configured to immobilize a head of a patient,includes a screw-type pitch adjustment mechanism;

FIG. 15A illustrates an exploded view of exemplary components of thepitch adjustment mechanism of FIG. 14;

FIGS. 15C depict the interconnection and inter-operation of componentsof the pitch adjustment mechanism of FIG. 15A;

FIGS. 16A and 16B illustrate interconnection of the shell frame platewith the shell frame of FIG. 14;

FIGS. 17A and 17B illustrate the interconnection of the pitch adjustmentmechanism with the support base of FIG. 14; and

FIGS. 18-20 illustrate adjustment of the pitch of the shell framerelative to the support base using the pitch adjustment mechanism of theembodiment of FIG. 14.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The following detailed description refers to the accompanying drawings.The same reference numbers in different drawings may identify the sameor similar elements. The following detailed description does not limitthe invention.

A technique, in the field of radiation oncology, for holding body partsin a fixed position uses heat-formable structures that include a sheetof retention material that is stretched over the body part of thepatient. For example, for performing radiation treatment of a braintumor, the heat-formable structure includes a mask having a sheet ofretention material that is stretched over the patient's face. To formthe mask over the patient's face, a hot water bath or oven may be firstused to heat the material of the heat-formable structure such that thesheet of material becomes pliable and deformable. The heat-formable maskis then stretched over the patient's face, and the mask is allowed tocool and harden, permanently forming the mask to the shape of the faceof the patient. As an example, a mask having a sheet of thermoplasticretention material, after heating, may be stretched over a patient'sface, and then allowed to cool. Upon cooling, the mask, formed to thepatient's face, creates a structure that can be used to hold thepatient's head in a fixed position during radiation treatments.

After the sheet of thermoplastic retention material of the mask isstretched over the body part of the patient, a frame portion of the maskis attached to a patient support table using an attachment mechanism.Once attached to the support table, however, existing patient maskscannot correct for the incorrect positioning of the patient's body part.Additionally, when the mask frame is attached to the patient supporttable, the thermoplastic retention material must be stretched a largedistance to reach from an upper surface of the patient body (e.g., thepatient's face) part all the way down to the surface of the supporttable. Stretching the thermoplastic retention material to this extentmakes it thinner and less rigid than may be desirable.

Exemplary embodiments described herein relate to a body partimmobilization device that includes improvements over existing maskframe support and attachment structures. Exemplary embodiments describedherein include a deep shell frame that receives and positions a bodypart, where the shell has an inner shape that conforms to the shape ofthe body part being immobilized (e.g., a patient's head). The shellframe additionally may contain a cushion (e.g., head cushion) that iscustomized to fit the body part of the patient. For example, when thebody part is a patient's head, the depth of the shell frame enables thecustomized cushion to surround the head up to a mid-point of the head,providing a large contact surface area that permits a substantial areaof support for the head. The shell frame may additionally include anupper flange that permits “easy on/easy off” attachment of a mask frameto the flange. Docking of the mask frame at the upper flange of theshell frame eliminates the need to stretch the thermoplastic material ofthe mask all the way down to the support table surface, thereby,enhancing the thickness and rigidity of the mask material.

Exemplary embodiments described herein additionally include a supportbase, and a pitch adjustment mechanism and/or roll adjustment mechanismthat, when coupled to the shell frame, enable a pitch and/or roll of theshell frame to be adjusted relative to the support base. Adjustment ofthe pitch and/or roll of the shell frame enables a positioning of thebody part (e.g., positioning of the head within the immobilizationdevice) to be easily adjusted, to satisfy the positioning requirementsof the particular medical test or medical treatment being performed,without having to disconnect the mask frame from the shell frame, orwithout having to remove the mask frame from the body part beingimmobilized. The pitch adjustment mechanism and/or the roll adjustmentmechanism, as described herein, may include a locking mechanism thatlocks the pitch and/or the roll of the shell frame relative to thesupport base. The pitch adjustment mechanism, as further describedherein, may also include a calibrated pitch adjustment wheel thatoperates, in conjunction with pitch adjustment slots or notches formedin a bottom surface of the shell frame, to permit the pitch adjustmentto be adjusted in a precise and controlled manner. The precise pitchadjustment is performed, using the pitch adjustment wheel, by performinga “click by click” engagement of teeth of the pitch adjustment wheelwith the pitch adjustment slots or notches as the pitch adjust wheel isrotated.

A “mask,” as referred to herein, includes any structure having amaterial (e.g., a thermoplastic material) that can be pulled over anybody part of a patient to form fit the material to the body part. Insome embodiments, a “mask” enables the body part to be immobilized andheld in a specific position using a fastening mechanism(s) that may, ormay not, be a component of the mask. Thus, a “mask,” as used herein,does not refer solely to a structure for placement over a patient's faceor head, but includes any type of structure for placement over any bodypart, or any portion of the body, of a patient (e.g., a structure thatpulls over a pelvis of a patient).

FIGS. 1A-1E depict views of a first exemplary embodiment in which a bodypart immobilization device 100 is configured to immobilize a head 110 ofa patient. As shown in FIG. 1A, immobilization device 100 includes asupport base 120 and a shell frame 130. Shell frame 130 may include anapproximate half shell structure having an inner surface that isconfigured to conform to a back of the patient's head and neck. The halfshell structure of shell frame 130 has a shape that approximates half ofa three-dimensional spheroid, where the half roughly transects avertical center of the spheroid. Shell frame 130 may include a neckcutout 140 in one side of the shell frame 130 that is configured toconform to the neck 150 of the patient and enables, when the patient'shead 110 is laid within shell frame 130, the neck 150 to extend out ofthe interior of shell frame 130. As shown, support base 120 includes afirst pitch shell ramp 160 and a second pitch shell ramp 170 that aredisposed on support base 120 opposite one another and at a sufficientdistance apart to enable the lower surface of shell frame 130 to restupon support base 120 between the two pitch shell ramps when in ahorizontal, non-pitch adjusted position. Pitch shell ramp 160 and pitchshell ramp 170 include sloping ramps that extend downwards towards acenter of support base 120. Shell frame 130 and support base 120 may beformed from various types of materials, including metal, plastic, carbonfiber, or a composite material. Shell frame 130 and support base 120 mayeach be formed from a same type of material, or a different type ofmaterial. For example, support base 120 may be formed from metal, andshell frame 130 may be formed from a composite material.

FIGS. 1B-1E depict examples of the adjustment of a pitch of shell frame130 relative to support base 120. As shown in the three-dimensional viewof FIG. 1B, and the one-dimensional side view of FIG. 1C, pitchadjustment involves the movement (i.e., sliding) of a bottom surface ofshell frame 130 up an upper surface of pitch ramp 160 (and down an uppersurface of pitch ramp 170), or up the upper surface of pitch ramp 170(and down the upper surface of pitch ramp 160. As further shown in FIG.1D, movement of the bottom surface of shell frame 130 up pitch ramp 170causes the side of shell frame adjacent the lower portion of the head110 of the patient to pitch upwards and the side of the shell frame 130adjacent the upper portion of the head 110 to pitch downwards. As alsoshown in FIG. 1E, movement of the bottom surface of shell frame 130 uppitch ramp 160 causes the side of shell frame 130 adjacent the upperportion of the head 110 of the patient to pitch upwards and the side ofthe shell frame 130 adjacent the lower portion of the head 110 to pitchdownwards.

As depicted in FIG. 1F, a head cushion 175 may be placed within shellframe 130 to cushion the patient's head 110 (not shown) against shellframe 130. Given the deep nature of shell frame 130, the head cushion175 surrounds the head 110 (not shown) up to a top of shell frame 130,thus, providing a large contact surface area and good support for thehead 110. With the head 110 supported upon head cushion 175, a mask 180and mask frame 185 may be docked to shell frame 130 using variousfastening mechanisms. In the exemplary embodiment depicted in FIG. 1F,multiple spring clips 190 may be used to fasten mask frame 185 to shellframe 130. The multiple spring clips 190 may be integral to the maskframe 185, may be integral to the shell frame 130, or may be separateand detached items that can be used to fasten mask frame 185 to shellframe 130 when mask frame 185 is docked with shell frame 130.

FIGS. 2A-2C depict further details of the pitch adjustment mechanism,and shell frame 130 to support base 120 interface components, involvedin pitch adjustment of shell frame 130 of the body part immobilizationdevice 100. As shown in FIG. 2A, a pitch adjustment mechanism 200,exemplary details of which are described further below, may be locatedon an underside of pitch ramp 160 of support base 120. Pitch adjustmentmechanism 200 controls the adjustment of the pitch of shell frame 130relative to support base 120. As shown in FIG. 2A, shell frame 130 restsin contact with support base 120 in a nominal horizontal position inwhich a center line of shell frame 130 is equidistant between pitchramps 160 and 170. A channel retention tab 210 may mount to support base120, on each side of shell frame 130 (only one tab 210 depicted in FIG.2A), to “channel” or restrict movement of shell frame 130 by preventingsideways movement and permitting movement in a single dimension thatincludes movement up or down either of pitch ramps 160 and 170. In otherembodiments, other guide structures may be used in lieu of channelretention tabs 210, such as ribs or rails formed into an upper surfaceof support base 120 between pitch ramps 160 and 170.

FIGS. 2B and 2C depict the shell frame 130 to support base 120 interfacecomponents involved in pitch adjustment of shell frame 130. As shown inFIG. 2B, an upper flange of an adjustment fastener 230 of the pitchadjustment mechanism 200 rests against an upper surface within a lowerpoint within the shell frame 130, where the adjustment fastener 230extends through the shell frame 130 into the support base 120 below.Shell movement pins 240 include upper flanges that rest against theupper surface at multiple locations within the shell of shell frame 130.Shell movement pins 240 extend through shell frame 130 into shellmovement slots (not shown in FIG. 2B) of support base 120. Referring toFIG. 2C, shell movement pins 240 are depicted as extending through shellframe 130 into shell movement slots 250 located within pitch ramps 160and 170 of support base 120. Shell movement slots 250 permit movement ofshell movement pins 240 such that shell frame 130 can move up and/ordown pitch ramps 160 and 170 via use of pitch adjustment mechanism 200.

FIGS. 2A-2C show immobilization device 100 as including a pitchadjustment mechanism 200 for use in adjusting a pitch of shell frame 130relative to support base 120, with further details of an exemplaryembodiment of pitch adjustment mechanism 200 being shown below withrespect to FIGS. 5A-5E. However, in another implementation, pitchadjustment mechanism 200 may be removed from immobilization device 100such that there is no pitch adjustment mechanism 200 for use inadjusting the pitch of shell frame 130. In this implementation, a usermay merely apply manual force to shell frame 130 to cause the pitch ofshell frame 130 to change relative to support base 120, without havingto use any type of pitch adjustment mechanism 200. Furthermore, in thisimplementation, shell movement pins 240 may include lower flanges (orother means of retaining shell movement pins 240 within shell movementslots 250), in addition to upper flanges, that retain shell frame 130within shell movement slots 250 such that shell frame 130 and shellmovement pins 240 do not easily come out of shell movement slots 250.

Though not depicted in FIGS. 2A-2C, immobilization device 100 mayadditionally include pitch adjustment reference markers located uponeither support base 120 and/or shell frame 130 that enable a visualinspection of a quantifiable amount of how much the pitch of shell frame130 has been adjusted in either direction (i.e., up or down). Thesepitch adjustment reference markers, therefore, enable accurate andprecise adjustments of the pitch of shell frame 130 to be made using avisual inspection. In one implementation, the pitch adjustment referencemarkers may be included upon a sticker that is applied at an appropriatelocation upon either support base 120 or shell frame 130 to show howmuch pitch has been applied to shell frame 130. In anotherimplementation, the pitch adjustment reference marks may be appliedalong a side surface of pitch ramp 160, and correspondingly along alower side surface of shell frame 130. Thus, movement of the pitchadjustment reference marks applied to the lower side surface of shellframe 130 relative to pitch adjustment reference marks applied to theside surface of pitch ramp 160, as the pitch of shell frame 130 isadjusted, enable a visual inspection to ascertain an amount of pitchapplied to shell frame 130 relative to support base 120. Other locationsupon shell frame 130 and/or support base 120 may be used for applyingpitch adjustment reference markers.

FIGS. 3A-3D depict four different views of support base 120, including atop view in FIG. 3A, a side view in FIG. 3B, a rear view in FIG. 3C, anda front view in FIG. 3D. As can be seen in the views of FIGS. 3A and 3B,a roughly flat and planar lower member of support base 120 connects toopposing pitch ramps 160 and 170. Rearward pitch ramp 160 may haveapproximately twice the height of forward pitch ramp 170, and each ofpitch ramps 160 and 170 may have concave inner ramps that extend fromthe planar lower member of support base 120 to a top of pitch ramps 160and 170. Pitch ramps 160 and 170 may be formed integrally to supportbase 120 (i.e., formed from the same material and formed as a singlestructure), or may be formed as separate components, and then connectedto support base 120 (e.g., snapped into place upon support base 120). Asshown in FIG. 3C, a pitch adjustment slot 300 extends through pitch ramp160, and is approximately centered upon the concave inner surface ofpitch ramp 160. Pitch adjustment slot 300 extends a certain length downthe concave inner surface of pitch ramp 160 and sets the maximumadjustment distance that the pitch of shell frame 130 may be adjusted.As can further be seen in FIG. 3C, two shell movement slots 250 extendthrough pitch ramp 160, and are located towards each outer edge of pitchramp 160 and towards a lower portion of the concave inner surface ofpitch ramp 160. FIG. 3D further depicts pitch ramp 160 from an oppositeside to that shown in FIG. 3C. In this front view, pitch adjustment slot300 and shell movement slots 250 are shown extending through the concaveinner surface of the pitch ramp 160. A rear of pitch ramp 170 canfurther be seen in FIG. 3D.

FIGS. 4A-4D depict four different views of shell frame 130 of device100, including a top view in FIG. 4A, a side view in FIG. 4B, a rearview in FIG. 4C, and a front view in FIG. 4D. As can be seen in theviews of FIGS. 4A - 4D, shell frame 130 includes a half shell structurehaving an inner surface that is configured to conform to a back of thepatient's head and neck. The half shell structure of shell frame 130 hasa shape that approximates half of a three-dimensional spheroid, wherethe half roughly transects a center of the spheroid. Shell frame 130 mayinclude a neck cutout 140 in one side of the shell frame 130 thatincludes an opening in the half shell that is configured to conform tothe neck 150 of the patient and enables, when the patient's head 110 islaid within shell frame 130, the neck 150 to extend out of the interiorof shell frame 130 through the neck cutout 140.

As shown in FIGS. 4A-4D, an upper edge of shell frame 130 includes aflange 400 that extends around a perimeter of the upper edge of theshell frame 130. The flange extends approximately ½ to ¾ of an inch outfrom the upper edge of shell frame 130. As can further be seen in FIGS.4A-4D, a recessed pitch foot 220 is formed in a lower surface of shellframe 130. Pitch foot 220 includes a roughly rectangular recess (as seenfrom the top view of FIG. 4A) formed in the lower surface of shell frame130 that serves as the “foot” of the shell frame 130 that rests upon thepitch ramps 160 and 170 of the underlying support base 120 (not shown inFIGS. 4A-4D). The pitch foot 220 “wraps” around the convex lower surfaceof shell frame 130 and may be centered about a first center line thatextends side-to-side through shell frame 130 and may be centered about asecond center line that extends front-to-back through shell frame 130.

As further seen in FIGS. 4A-4D, pitch foot 220 further includes a pitchadjustment fastener retention hole 410 and multiple shell movement pinretention holes 420. Pitch adjustment fastener retention hole 410retains a pitch adjustment fastener (described below) of the pitchadjustment mechanism 200, where the pitch adjustment fastener extendsthrough retention hole 410, and through pitch adjustment slot 300 insupport base 120. Further details of the exemplary pitch adjustmentmechanism 200 are described below with respect to FIGS. 5A-5E. Shellmovement pin retention holes 420 retain shell movement pins 240 (shownin FIGS. 2B and 2C) that extend through retention holes 420, and throughshell movement slots 250 (shown in FIG. 2C) in the pitch ramps 160 and170 of support base 120. Shell movement pins 240 (not shown in FIGS.4A-4D) each include an upper flange that rests against the inner surfaceof shell frame 130 within pitch foot 220. The upper flange of each shellmovement pin 240, in combination with the retention hole 420 each pinextends through, hold each shell movement pin 240 in place within shellframe 130.

FIG. 4E depicts further exemplary details of flange 400 of shell frame130. As shown, an upper surface of flange 400 includes multipleregistration holes 430, and multiple registration tabs 440 for docking aframe of a body part mask (not shown) to shell frame 130. The frame ofthe body part mask (not shown) may include multiple pins, on anunderside of the frame, that line up with, and can be inserted into,registration holes 430. The frame of the body part mask (not shown) mayfurther include its own registration holes, which extend through theframe and line up with, and can be inserted over, registration tabs 440.Therefore, when docking the body part mask to shell frame 130, theregistration holes 430 and registration tabs 440, ensure the properpositioning of the body part mask relative to shell frame 130.

FIGS. 5A-5E depict details of an exemplary embodiment of pitchadjustment mechanism 200. In the exemplary embodiment of FIGS. 5A-5E,pitch adjustment mechanism 200 includes a clamp-type adjustmentmechanism. FIG. 5A depicts a view of the overall operation of pitchadjustment mechanism 200, that doesn't show shell frame 130 for purposesof simplicity. As shown, an adjustment fastener 230 of pitch adjustmentmechanism 200 extends through pitch adjustment slot 300 of support base120. Movement of pitch adjustment mechanism 200, to adjust the pitcheither to the left or to the right in FIG. 5A, correspondingly causesshell movement pins 240 (which are attached to shell frame 130) to moveto the left or to the right in pitch movement slots 250. Movement ofshell movement pins 240 within pitch movement slots 250 results in shellframe 130 (not shown in FIG. 5A) moving in a “channel” created bychannel retention tabs 210 that prevent any sideways movement of shellframe 130. FIG. 5B illustrates the pitch adjustment mechanism 200 ofFIG. 5A in an “exploded view” such that the individual components can bediscerned. FIG. 5C further depicts a close up of the “exploded view” ofthe pitch adjustment mechanism 200 of FIG. 5B. Pitch adjustmentmechanism 200, in this embodiment, includes four components, anadjustment fastener 230, a locking spacer 500, an adjustment/lockingknob 505, and an adjustment pin (not shown).

Locking spacer 500 includes a spacer hole 525. An additional break outview 560 of locking spacer 500 is depicted in FIG. 5C, showing the sizeof spacer hole 525 relative to the shape and size of spacer 500. Lockingspacer 500 has an oval shape, with an oval shaped spacer hole 525centered within the oval shape of spacer 500. Locking spacer 500 has athickness of approximately 1/8 of an inch, and may be formed fromvarious types of materials, such as metal, plastic, carbon fiber, or acomposite material. The oval shaped spacer hole 525 has a size thatpermits insertion of adjustment fastener 230 through spacer hole 525.

Adjustment fastener 230 further includes a fastener body 510, a flange515, and a fastener pin retention hole 520. Additional break out views550 and 555 of adjustment fastener 230 are depicted in FIG. 5C, showingthe shape of adjustment fastener 230 from different viewing angles.Fastener body 510, as shown in the front break out view 550, has an ovalshape for insertion through the oval spacer hole 525 of locking spacer500. Fastener pin retention hole 520 permits an adjustment pin (notshown) to be inserted into the retention hole 520, as described furtherbelow. Flange 515 is disposed at one end of fastener body 510, and pinretention hole 520 is disposed close to another end of fastener body510. Flange 515 has an oval shape that is larger than the oval shape offastener body 510, such that flange 515 extends outwardly from the outersurface of fastener body 510.

Adjustment/locking knob 505 further includes an adjustment body 530, apin retention hole 535, an adjustment knob 540, and a locking extension545. A break out view 565 of adjustment/locking knob 505 is alsodepicted in FIG. 5C, showing a fastener slot 570 that receives a portionof fastener body 510 that includes the fastener pin retention hole 520.To combine knob 505, spacer 500 and fastener 230 to create pitchadjustment mechanism 200 (or to create roll adjustment mechanism 720described below), fastener body 510 is inserted through hole 525 ofspacer 500 and into fastener slot 570 such that pin retention hole 535lines up with pin retention hole 520. The adjustment pin (not shown) canthen be inserted through pin retention hole 535 of knob 505 into pinretention hole 520 of fastener 230 such that the adjustment pin can thenserve as an “axle” about which the entirety of adjustment/locking knob505 rotates when force is applied to adjustment knob 540.

Adjustment knob 540 includes, for example, a rectangular touch surfacevia which force may be applied to cause the rotation ofadjustment/locking knob 505. Adjustment knob 540 connects to adjustmentbody 530, which has a roughly cylindrical shape through which pinretention hole 535 extends on a forward surface, and into which fastenerslot 570 extends on a side surface. Locking extension 545 connects to aside surface of adjustment body 530, creating, for example, a reversed“e” shape seen in the main view depicted in FIG. 5C.

FIG. 5D depicts the interaction of the components of pitch adjustmentmechanism 200 to lock and unlock the pitch adjustment of mechanism 200.In FIG. 5D, the leftmost view depicts pitch adjustment mechanism 200 inan initial, unlocked state in which the pitch of shell frame 130 (notshown) may be adjusted by moving fastener body 510 within pitch movementslot 300 of support base 120 (also not shown in FIG. 5D). As force isapplied to adjustment knob 540 (shown with an arrow in the leftmost viewof FIG. 5D), adjustment/locking knob 505 rotates about the adjustmentpin (not shown) inserted through pin retention hole 535.

As further shown in the center view of FIG. 5D, as adjustment/lockingknob 505 continues to rotate about the adjustment pin, the lower surfaceof knob 505, including locking extension 545, begins forcing lockingspacer 500 in an upwards direction towards flange 515 of adjustmentfastener 230 and also begins pulling adjustment fastener 230 in adownwards direction. As locking spacer 500 moves in the upwardsdirection, it applies force against the bottom surface of pitch ramp 160of support base 120, and as adjustment fastener 230 moves in thedownwards direction, the flange 515 of adjustment fastener 230 istightened against an upper surface of shell frame 130. In anotherembodiment (not shown), adjustment/locking knob 505 may, instead of thereversed “e” shape shown in FIG. 5C, include a cam.

The rightmost view of FIG. 5D depicts adjustment/locking knob 505 in alocked position in which the force applied by locking spacer 500 againstthe bottom surface of pitch ramp 160 of support base 120, and the forceapplied by flange 515 of adjustment fastener 230 against an uppersurface of shell frame 130 causes shell frame 130 to be held in place,at a desired pitch position, relative to support base 120. This view ofFIG. 5D shows locking extension 545 in a locked position that appliesthe maximum upwards force against locking spacer 500 which, in turn,applies the maximum upwards force against the lower surface of supportbase 120. With locking extension 545 in the locked position, fastenerbody 510 is pulled downwards with a maximum “position locking” force,causing flange 515 to apply a maximum “position locking” force againstan upper surface of shell frame 130. The “position locking” force causedby rotation of adjustment/locking knob 505 against locking spacer 500locks shell frame 130 into a particular level of pitch. The pitch ofshell frame 130 can be “unlocked” by reversing (i.e., starting with therightmost view, and proceeding to the middle view, and then to theleftmost view) the rotation of adjustment/locking knob 505 shown in FIG.5D. FIG. 5E shows pitch adjustment mechanism 200 rotated into a lockedposition, causing shell frame 130 to be held at a certain position uponpitch ramp 160 such that shell frame 130 has a certain pitch relative tosupport base 120.

FIGS. 6A-6E depict details of an additional exemplary embodiment inwhich pitch adjustment mechanism 200 further includes a pitch adjustmentwheel assembly that permits a precise, calibrated adjustment of thepitch of shell frame 130 relative to support base 120. Pitch adjustmentmechanism 200 is shown in FIG. 6A as including the additional pitchadjustment wheel assembly 600 mounted on the underside of pitch ramp 160of support base 160, adjacent to pitch adjustment/locking knob 505.

FIG. 6B further shows a top view of support base 120 and additionaldetails of pitch adjustment wheel assembly 600. In the close-up view,pitch adjustment wheel assembly 600 is depicted as including acylindrical pitch wheel 610 having pitch adjustment teeth 630 thatextend through a rectangular pitch adjustment port 620 formed throughthe underside of pitch ramp 160. As can be seen in subsequent figures,the teeth of pitch wheel 610 engage with corresponding notches/slots inthe underside of shell frame 130, and when pitch wheel 610 is rotated,cause the pitch of shell frame 130 to be adjusted.

FIG. 6C depicts further details of pitch adjustment wheel assembly 600.As shown, pitch wheel 610 mounts to triangular wheel mounts 640 via awheel axle (not shown) that extends through the wheel mount holes 650 ineach of wheel mounts 640. Pitch wheel 610 may, therefore, rotate in aclockwise, or counterclockwise, direction by rotating about the wheelaxle and wheel mount holes 650. As pitch wheel 610 rotates, the teeth ofpitch wheel 610 that extend through pitch adjustment port 620 in pitchramp 160, engage, as described further below with respect to FIG. 6D,the underside of shell frame 130 causing the pitch of shell frame 130 tobe adjusted in periodic, discrete increments.

FIG. 6D depicts further details of the teeth of pitch wheel 610adjusting the pitch of shell frame 130. As seen in FIG. 6D, shell frame130 includes a series of pitch adjustment slots 670 that are formed fromthe underside of shell frame 130 through to the upper surface of shellframe 130. The pitch adjustment slots 670 match the shape and size ofthe teeth 630 of pitch wheel 610 located beneath shell frame 130 on theunderside of support base 120. As pitch wheel 610 is rotated in aclockwise direction, the teeth 630 of pitch wheel 610 engage pitchadjustment slots 670 and cause shell frame 130 to move downwards (to theright), in the close-up view of FIG. 6D. Further, as pitch wheel 610 isrotated in a counterclockwise direction, the teeth 630 of pitch wheel610 engage pitch adjustment slots 670 and cause shell frame 130 to moveupwards (to the left), in the close-up view of FIG. 6D. Each “click byclick” adjustment of pitch wheel 610 causes a precise adjustment (e.g.,1°, 0.5°, etc.) of the pitch of shell frame 130 via interaction of theteeth 630 of pitch wheel 610 with the pitch adjustment slots 670 ofshell frame 130.

FIG. 6E depicts a cross-sectional cutaway view of pitch adjustment wheelassembly 600. As pitch wheel 610 is rotated in a clockwise direction(“CW”), the teeth 630, extending through pitch adjustment port 620 inpitch ramp 160, engage with the pitch adjustment slots 670 in the bottomsurface of shell frame 130. Engagement of the teeth 630 of pitch wheel610 with pitch adjustment slots 670 causes shell frame 130 to moveupwards, in the view shown in FIG. 6E, as pitch wheel 610 is rotatedclockwise. Alternatively, as pitch wheel 610 is rotated in acounterclockwise direction, the teeth 630, extending through pitchadjustment port 620 in pitch ramp 160, engage with the pitch adjustmentslots 670 in the bottom surface of shell frame 130. Engagement of theteeth 630 of pitch wheel 610 with pitch adjustment slots 670 causesshell frame 130 to move downwards, in the view shown in FIG. 6E, aspitch wheel 610 is rotated counterclockwise.

FIG. 7 illustrates another exemplary embodiment of a body partimmobilization device 700 that includes, in addition to a pitchadjustment mechanism, a roll adjustment mechanism that permits the shellframe 130 (and the patient body part placed within the shell frame 130),to be “rolled” relative to the support base 120 of the device 700. Asshown in FIG. 7, body part immobilization device 700 includes a supportbase 120 and a shell frame 130 similar to the embodiment of FIG. 1.Shell frame 130 may include an approximate half shell structure havingan inner surface that is configured to conform to a back of thepatient's body part (e.g., head and neck). In the implementationdepicted in FIG. 7, the half shell structure of shell frame 130 has ashape that approximates half of a three-dimensional spheroid, where thehalf roughly transects a vertical center of the spheroid. Shell frame130 may include a cutout 140 in one side of the shell frame 130 that isconfigured to conform to the body part (e.g., neck or other body part)of the patient and enables, when the patient's body part (e.g., head) islaid within shell frame 130, the attaching body component (e.g., neck)to extend out of the interior of shell frame 130. Support base 120 maybe configured similarly to that shown, and described, above with respectto body part immobilization device 100.

As shown in FIG. 7, device 700 further includes a shell frame carriage710 upon which shell frame 130 rests. Shell frame carriage 710 restsupon first pitch ramp 160 and second pitch ramp 170, which are furtherdisposed on support base 120 opposite one another and at a sufficientdistance apart to enable the lower surface of shell frame carriage 710to rest upon support base 120 between the two pitch ramps 160 and 170when oriented in a horizontal, non-pitch adjusted position. Pitch ramp160 and pitch ramp 170 include sloping ramps that extend downwardstowards a center of support base 120. Shell frame 130, shell framecarriage 710, and support base 120 may be formed from various types ofmaterials, including, for example, metal, plastic, carbon fiber, and/ora composite material. Shell frame 130, shell frame carriage 710, andsupport base 120 may each be formed from a same type of material, or adifferent type of material. For example, support base 120 may be formedfrom metal, and shell frame 130 and shell frame carriage 710 may beformed from a plastic or a composite material. As shown in FIG. 7, anddescribed in further detail below, device 700 includes a pitchadjustment mechanism 200 for adjusting the pitch of shell frame 130 andshell frame carriage 710, and additionally includes a roll adjustmentmechanism 720 for adjusting the roll of shell frame 130.

FIG. 8A depicts an exploded three-dimensional view of body partimmobilization device 700 of FIG. 7. Support base 120 includes a similarphysical configuration to that described with respect to device 100 ofFIGS. 1A-1F above. Shell frame carriage 710 includes a tray-like shapehaving an upper surface that conforms to the spheroid lower surface ofshell frame 130, and a lower surface that conforms to the upper surfaceof support base 120, including the upper surface of pitch ramp 160 andpitch ramp 170. As shown, the lower surface of shell frame carriage 710rests upon the upper surface of support base 120, including resting onthe upper surfaces of pitch ramp 160 and pitch ramp 170. The lowersurface of shell frame 130 rests upon the upper surface of shell framecarriage 710, with shell movement pins 800 extending through holes inshell frame 130 into corresponding shell movement slots (described infurther detail below) in shell frame carriage 710. Pitch adjustmentmechanism 200 enables the adjustment of the pitch of shell framecarriage 710, which further adjusts the pitch of shell frame 130 thatrides within shell frame carriage 710. Roll adjustment mechanism 720enables the adjustment of the roll of shell frame 130 within shell framecarriage 710.

FIG. 8B is a three-dimensional view of the components of body partimmobilization device 700 that are involved in adjustment of the pitchof shell frame carriage 710 and shell frame 130. As shown in the mainview of FIG. 8B, carriage movement pins 820 extend through correspondingholes in shell frame carriage 710 into movement slots 250 within pitchramp 160 and pitch ramp 170. As further depicted in the break-out viewof FIG. 8B, adjustment fastener 230 of pitch adjustment mechanism 200extends through a hole 810, in a rear surface of shell frame carriage710, that is located so as to align with pitch adjustment slot 300within pitch ramp 160. Locking spacer 500 fits over adjustment fastener230, and adjustment/locking knob 505 fits over, and attaches to,adjustment fastener 230. Operation of adjustment/locking knob 505 mayenable the pitch of shell frame carriage 710 and shell frame 130 to be“locked” into a certain pitch position. Operation of the pitchadjustment of body part immobilization device 700 is described infurther detail below with respect to FIGS. 11A and 11B.

FIG. 8C is a three-dimensional view of the components of body partimmobilization device 700 that are involved in adjustment of the roll ofshell frame 130. As shown in the main view of FIG. 8C, shell movementpins 800 extend through corresponding holes in shell frame 130 intomovement slots 830 within shell frame carriage 710, where movement slots830 are oriented in a transverse direction to movement slots 250 inpitch ramps 160 and 170. As further depicted in the break-out view ofFIG. 8C, adjustment fastener 230 of roll adjustment mechanism 720extends through a roll fastener hole 850 within shell frame 130, andthrough a corresponding hole 840 in a forward surface of shell framecarriage 710 that is aligned with the roll fastener hole 850 withinshell frame 130. Hole 840 in shell frame carriage 710 is sized largerthan roll fastener hole 850 in shell frame 130 to permit rotational“roll” movement of shell frame 130. Locking spacer 500 fits overadjustment fastener 230, and adjustment/locking knob 505 fits over, andattaches to, adjustment fastener 230 such as described with respect toFIG. 5C above. Operation of adjustment/locking knob 505 may enable theroll of shell frame 130, within shell frame carriage 710, to be “locked”into a certain roll position. Operation of the roll adjustment of bodypart immobilization device 700 is described in further detail below withrespect to FIGS. 13A and 13B.

FIGS. 9A-9D depict four different views of shell frame 130 of body partimmobilization device 700, including a top view in FIG. 9A, a side viewin FIG. 9B, a rear view in FIG. 9C, and a front view in FIG. 9D. As canbe seen in the views of FIGS. 9A-9D, shell frame 130 includes a halfshell structure having an inner surface that is configured to conform toa back of the patient's head and neck. The half shell structure of shellframe 130 has a shape that approximates half of a three-dimensionalspheroid, where the half roughly transects a center of the spheroid.Shell frame 130 may include a neck cutout 140 in one side of the shellframe 130 that includes an opening in the half shell that is configuredto conform to the neck 150 (not shown) of the patient and enables, whenthe patient's head 110 (not shown) is laid within shell frame 130, theneck 150 (not shown) to extend out of the interior of shell frame 130through the neck cutout 140.

As shown in FIGS. 9A-9D, an upper edge of shell frame 130 includes aflange 910 that extends around a perimeter of the upper edge of theshell frame 130. The flange 910 extends approximately ½ to ¾ of an inchout from the upper edge of shell frame 130. As can further be seen inFIGS. 9A and 9B, shell frame 130 includes two shell movement pin holes900 located in the vicinity of the bottom of shell frame 130. Shellmovement pin holes 900 receive corresponding shell movement pins 800(not shown) and line up with respective movement slots 830 (not shown)within shell frame carriage 710 (not shown). FIGS. 9C and 9D furtherdepict roll fastener hole 850 and rotation hole 920. Though not shown inFIGS. 9C and 9D, adjustment fastener 230 of roll adjustment mechanism720 extends through roll fastener hole 850 into hole 840 in shell framecarriage 710, and a fastening mechanism, such as, for example, a screwand nut, extends through rotation hole 920 to rotatably fasten shellframe 130 to shell frame carriage 710 such that shell frame 130 mayrotate about a central axis formed within rotation hole 920 as the rollof shell frame 130 is adjusted relative to shell frame carriage 710 andsupport base 120. Flange 910 of device 700 may be similar to flange 400of device 100, with multiple registration and alignment holes beingdisposed around a perimeter of flange 910, and with each registrationhole extending from an upper surface of flange 910 through to a lowersurface of flange 910. The frame of the body part mask (not shown) mayinclude multiple pins, on an underside of the frame, that line up with,and can be inserted into, the registration and alignment holes of flange910. Therefore, when docking the body part mask to shell frame 130, theregistration and alignment holes of flange 910, in conjunction with themultiple pins on the underside of the body part mask frame, ensure theproper positioning of the body part mask relative to shell frame 130.

FIGS. 10A and 10B depict support base 120 and shell frame carriage 710of device 700 in a horizontal position prior to any adjustment beingapplied to change the pitch of shell frame carriage 710 relative tosupport base 120. With shell frame carriage 710 residing in a non-pitchadjusted position, such as shown in FIGS. 10A and 10B, shell framecarriage pins 820 extend through corresponding holes in shell framecarriage 710 and into carriage movement slots 250 (not shown) of pitchramps 160 and 170 at a midpoint within the length of slots 250. Toadjust the pitch of shell frame carriage 710 and shell frame 130,adjustment/locking knob 505 of pitch adjustment mechanism 200 may berotated to an “unlocked” position. As can be seen in FIG. 10B, whenadjustment/locking knob 505 is rotated to a locked position, adjustmentfastener 230 pulls shell frame carriage 710 against the upper surface ofsupport base 120 such that shell frame carriage 710 (and shell frame130, which rests within carriage 710) is held in a fixed pitch positionrelative to support base 120. To adjust the pitch of shell framecarriage 710 and shell frame 130, adjustment/locking knob 505 of pitchadjustment mechanism 200 may be rotated to an unlocked position (theopposite direction to that shown in FIG. 10B), loosening the holdadjustment fastener 230 has on shell frame carriage 710. Withadjustment/locking knob 505 rotated to an unlocked position, adjustmentfastener 230 no longer pulls shell frame carriage 710 against the uppersurface of support base 120, thus, enabling the pitch of shell framecarriage 710 and shell frame 130 to be adjusted, as described below withrespect to FIGS. 11A and 11B. When the pitch of shell frame carriage 710is adjusted, carriage movement pins 820 ride within movement slots 250of support base 120, either to the left or to the right, in the viewdepicted in FIG. 10B, depending on the direction of pitch being appliedto shell frame carriage 710 and shell frame 130.

FIGS. 11A and 11B depict adjustment of the pitch of shell frame carriage710 (and shell frame 130, which rides within carriage 710). In FIG. 11A,the rear of shell frame carriage 710, and shell frame 130 (not shown)resting within carriage 710, is pitched upwards upon pitch ramp 160 andthe front of shell frame carriage 710 is simultaneously pitcheddownwards upon pitch ramp 170 by sliding the lower surface of carriage710 upon pitch ramps 160 and 170. As the pitch of shell frame carriage710 is adjusted, carriage movement pins 820 ride within movement slots250 (not shown) of support base 120. Each of movement slots 250 has aslot length that limits that amount of pitch adjustment in eitherdirection. In FIG. 11B, the rear of shell frame carriage 710, and theshell frame 130 (not shown) resting within carriage 710, is pitcheddownwards upon pitch ramp 160 and the front of shell frame carriage 710is simultaneously pitched upwards upon pitch ramp 170 by sliding thelower surface of carriage 710 upon pitch ramps 160 and 170.

FIG. 12 depicts shell frame 130, shell frame carriage 710, and supportbase 120 of device 700 in a horizontal position prior to any rolladjustment being applied to change the roll of shell frame 130 relativeto shell frame carriage 710 and support base 120. With shell frame 130residing in a non-roll adjusted position, such as shown in FIG. 12,shell frame pins 800 (not shown) extend into corresponding shellmovement slots 830 in shell frame carriage 710 at a midpoint within thelength of slots 830. To adjust the roll of shell frame 130,adjustment/locking knob 505 of roll adjustment mechanism 720 may berotated from a “locked” position to an “unlocked” position (shown withthe arrow in an upward direction in FIG. 12). In the exemplaryimplementation depicted in FIG. 12, when adjustment/locking knob 505 isrotated to an unlocked position, adjustment fastener 230 no longer pullsshell frame 130 against the upper surface of shell frame carriage 710such that shell frame 130 is not held in a fixed position relative toshell frame carriage 710, and the roll of shell frame 130 may beadjusted using roll adjustment mechanism 720.

The operation of roll adjustment mechanism 710 is described in furtherdetail with reference to FIG. 5D. In the rightmost view of FIG. 5D,adjustment/locking knob 505 is in a locked position in which the forceapplied by locking spacer 500 against the bottom surface of shell framecarriage 710, and the force applied by flange 515 of adjustment fastener230 against an upper surface of shell frame 130 causes shell frame 130to be held in place, at a desired roll position, relative to shell framecarriage 710 and support base 120. This rightmost view of FIG. 5D showslocking extension 545 in a locked position that applies the maximumupwards force against locking spacer 500 which, in turn, applies themaximum upwards force against the lower surface of shell frame carriage710. With locking extension 545 in the locked position, fastener body510 is pulled downwards with a maximum “position locking” force, causingflange 515 to apply a maximum “position locking” force against an uppersurface of shell frame 130. The “position locking” force caused byrotation of adjustment/locking knob 505 against locking spacer 500 locksshell frame 130 into a particular level of roll relative to shell framecarriage 710. The roll of shell frame 130 can be “unlocked” by reversing(i.e., starting with the rightmost view, and proceeding to the middleview, and then to the leftmost view) the rotation of adjustment/lockingknob 505 shown in FIG. 5D.

FIGS. 13A and 13B depict adjustment of the roll of shell frame 130relative to shell frame carriage 710 and support base 120. In FIG. 13A,the right side of shell frame 130 (viewed from the rear of shell frame130) is rolled downwards upon shell frame carriage 710, and the leftside of shell frame 130 is simultaneously rolled upwards upon shellframe carriage 710 by sliding the lower surface of shell frame 130 alongthe upper surface of shell frame carriage 710. As the roll of shellframe 130 is adjusted, shell movement pins 800 ride within shellmovement slots 830 of shell frame carriage 710. Each of shell movementslots 830 has a slot length that limits that amount of roll adjustmentin either direction. In FIG. 13B, the right side of shell frame 130(viewed from the rear of shell frame 130) is rolled upwards upon shellframe carriage 710 and the left side of shell frame 130 issimultaneously rolled downwards upon shell frame carriage 710, bysliding the lower surface of shell frame 130 along the upper surface ofshell frame carriage 710, to roll adjust shell frame 130 in an oppositedirection to that depicted in FIG. 13A. Once the roll of shell frame 130has been adjusted to the desired roll position, adjustment/locking knob505 of roll adjustment mechanism 720 may be rotated to a locked positionto tighten adjustment fastener 230 against shell frame 130. Withadjustment/locking knob 505 rotated to a locked position, adjustmentfastener 230 pulls shell frame 130 against the upper surface of shellframe carriage 710, thus, holding shell frame 130 in a fixed rollposition relative to shell frame carriage 710 and support base 120.

FIGS. 7-13B depict an exemplary embodiment of body part immobilizationdevice 700 that includes both a pitch adjustment mechanism and a rolladjustment mechanism. In other embodiments, however, body partimmobilization device 700 may include only the roll adjustment mechanism720 (and associated structure) and may not include the pitch adjustmentmechanism (i.e., pitch adjustment mechanism 200, and associatedstructure, is omitted from device 700).

FIG. 14 depicts another exemplary embodiment in which a body partimmobilization device 1400, configured to immobilize, for example, ahead of a patient, includes a screw-type pitch adjustment mechanism thatis different than the clamp-type pitch adjustment mechanism of theexemplary embodiment of FIGS. 5A-5E. As shown in FIG. 14, immobilizationdevice 1400 includes a support base 1405, a shell frame 1410, and ascrew-type pitch adjustment mechanism 1415. Shell frame 1410 may includean approximate half shell structure having an inner surface that isconfigured to conform to a back of the patient's head and neck. The halfshell structure of shell frame 1410 may have a shape that approximateshalf of a three-dimensional spheroid, where the half roughly transects avertical center of the spheroid. Shell frame 1410 may include a neckcutout 1420 in one side of the shell frame 1410 that is configured toconform to the neck of the patient. When the patient's head is laidwithin shell frame 1410, the patient's neck extends out of the interiorof shell frame 1410 through neck cutout 1420.

As shown, support base 1405 includes a first pitch shell ramp 1425 and asecond pitch shell ramp 1430 that are disposed on support base 1405opposite one another and at a sufficient distance apart to enable thelower surface of shell frame 1410 to rest upon support base 1405 betweenthe two pitch shell ramps when in a horizontal, non-pitch-adjustedposition. Pitch shell ramp 1425 and pitch shell ramp 1430 may includesloping ramps (e.g., concave ramps) that each extend downwards towards acenter of support base 1405. Shell frame 1410 and support base 1405 maybe formed from various types of materials, including metal, plastic,carbon fiber, or a composite material. Shell frame 1410 and support base1405 may each be formed from a same type of material, or a differenttype of material. For example, support base 1405 may be formed frommetal, and shell frame 1410 may be formed from a composite material.

An upper edge of shell frame 1410 may include a flange 1435 that extendsaround a perimeter of the upper edge of the shell frame 1410. The flangeextends approximately ½ to ¾ of an inch out from the upper edge of shellframe 1410. Shell frame 1410 may further include a recessed pitch foot1440 that is formed in a lower surface of shell frame 1410. Pitch foot1440 includes a roughly rectangular recess (similar to pitch foot 220shown in FIG. 4A) formed in the lower surface of shell frame 1410 thatserves as the “foot” of the shell frame 1410 that rests upon the pitchshell ramps 1425 and 1430 of the underlying support base 1405. The pitchfoot 1440 “wraps” around the convex lower surface of shell frame 1410and may be centered about a first center line that extends side-to-sidethrough shell frame 1410 and may be centered about a second center linethat extends front-to-back through shell frame 1410.

Screw-type pitch adjustment mechanism 1415 enables adjustment of a pitchof shell frame 1410 relative to support base 1405. As described furtherbelow, pitch adjustment involves the movement (i.e., sliding) of abottom surface (i.e., pitch foot 1440) of shell frame 1410 up an uppersurface of first pitch shell ramp 1425 (and down an upper surface ofsecond pitch shell ramp 1430), or up the upper surface of second pitchshell ramp 1430 (and down the upper surface of first pitch shell ramp1425). Movement of pitch foot 1440 of shell frame 1410 up second pitchshell ramp 1430 causes the side of shell frame 1410 adjacent the lowerportion of the head of the patient to pitch upwards and the side of theshell frame 1410 adjacent the upper portion of the head to pitchdownwards. Movement of pitch foot 1440 of shell frame 1410 up firstpitch shell ramp 1425 causes the side of shell frame 1410 adjacent theupper portion of the head of the patient to pitch upwards and the sideof the shell frame 1410 adjacent the lower portion of the head of thepatient to pitch downwards. Details of the configuration, and operation,of screw-type pitch adjustment mechanism 1415 is described furtherbelow.

FIG. 15A illustrates an exploded view of exemplary components of pitchadjustment mechanism 1415. Pitch adjustment mechanism 1415 may, asshown, include a pitch adjustment screw 1500, a pitch adjustment block1505, a screw retention collar 1510, a pitch screw yoke 1515, a shellframe plate 1520, pitch track screw assemblies 1525-1 and 1525-2,block-to-shell frame attachment screw 1530, block-to-plate attachmentscrew 1535, and plate position retention pin 1540.

Pitch adjustment screw 1500 includes a shank having a male thread thatscrews into threads into female threads of a corresponding hole of pitchadjustment block 1505. As described further below, adjustment of thescrew 1500 upwards and downwards within pitch adjustment block 1505changes the pitch of the shell frame 1410 relative to support base 1405.Screw retention collar 1510 fits within a slot (not shown-describedfurther with respect to FIG. 15B below) of pitch screw yoke 1515 toserve as a “clip” for retaining pitch adjustment screw 1500 in alinearly fixed configuration relative to pitch screw yoke 1515 followingassembly of pitch adjustment mechanism 1415. Rotation of pitchadjustment screw 1500 into, or out of, the female threads of pitchadjustment block 1505, causes pitch adjustment block 1505 to movelinearly towards, or away from, pitch screw yoke 1515. Movement of pitchadjustment block 1505 towards, or away from, pitch screw yoke 1515causes corresponding movement of shell frame 1410 (not shown), relativeto support base 1405, due to pitch adjustment block 1505 being attachedto shell frame 1410 (not shown-described further below with respect toFIGS. 16A and 16B) via screw 1530, and being attached to shell frameplate 1520 via screw 1535.

Pitch adjustment block 1505 attaches to shell frame 1410 (not shown) viablock-to-shell frame attachment screw 1530 and attaches to shell frameplate 1520 via block-to-plate attachment screw 1535. Pitch track screwassemblies 1525-1 and 1525-2 connect pitch screen yoke 1515 to pitchadjustment tracks (not shown in FIG. 15A) in a backside of shell frameplate 1520. Plate position retention pin 1540 inserts into acorresponding retention hole (not shown) in shell frame 1410 (not shown)to maintain a fixed position of shell frame plate 1520 relative to aninside surface of shell frame 1410.

FIG. 15B illustrates further details of the interconnection ofcomponents of pitch adjustment mechanism 1415, with pitch adjustmentblock 1505 shown as transparent. Pitch screw yoke 1515 includes a blockof material having approximately a V-shape, as seen from above, where ayoke slot 1545 creates an interior of the V-shape. An unthreaded portionof a shank of pitch adjustment screw 1500 inserts into yoke slot 1545,and pitch adjustment screw 1500 may be held in position within yoke slot1545 by screw retention collar 1510. Screw retention collar 1510 may beinserted into a slot in an underside of pitch screw yoke 1515 such thatthe unthreaded portion of the shank of screw 1500 extends through collar1510, and a flange 1550 on the shank of screw 1500 abuts against anunderside of screw retention collar 1510 to retain screw 1500 in a fixedposition relative to pitch screw yoke 1515. Pitch screw yoke 1515 mayinclude protrusions 1555-1 and 1555-2 on a forward surface of each armof the V-shape of pitch screw yoke 1515, with each protrusion 1555including a female threaded hole extending into the arm of yoke 1515.Protrusions 1555-1 and 1555-2 extend through corresponding holes in theunderside of support base 1405 (not shown) to anchor pitch screw yoke1515 in a fixed position against the underside of support base 1405. Aspitch adjustment screw 1500 is turned in one direction, pitch adjustmentblock 1505 moves in a first linear direction relative to pitch screwyoke 1515. As pitch adjustment screw 1500 is turned in an oppositedirection, pitch adjustment block 1505 moves in a second, oppositedirection relative to pitch screw yoke 1515. The direction in whichpitch adjustment block 1505 moves due to turning pitch adjustment screw1500 clockwise or counterclockwise depends on whether screw 1500 is aright-handed (RH) or left-handed (LH) screw. If, for example, screw 1500is a RH screw, then turning screw 1500 clockwise (CW) results in pitchadjustment block 1505 moving upwards (i.e., towards pitch screw yoke1515), and turning screw 1500 counterclockwise (CCW) results in pitchadjustment block 1505 moving downwards (i.e., away from pitch screw yoke1515).

A respective screw of pitch track screw assemblies 1525-1 and 1525-2attaches to female threaded holes of protrusions 1555-1 and 1555-2 on aforward surface of each arm of pitch screw yoke 1515. Block-to-plateattachment screw 1535 attaches to a forward surface of pitch adjustmentblock 1505. Block-to-shell frame attachment screw 1530 also attaches tothe forward surface of pitch adjustment block 1505. As described below,block-to-plate attachment screw 1535 further attaches to shell frameplate 1520 (not shown in FIG. 15B), and block-to-shell frame attachmentscrew 1530 further attaches to shell frame 1410 (also not shown).

FIG. 15C depicts the interconnection and inter-operation components ofpitch adjustment mechanism 1415 from a reverse view relative to FIG.15B, with pitch adjustment block 1505 and pitch screw yoke 1515 shown astransparent. As shown in the box in the upper right corner, each ofpitch screw assemblies 1525-1 and 1525-2 includes a pitch track screw1560, a pitch track screw collar 1565, and a pitch track screw spacer1570. Collar 1565 fits around a head of pitch track screw 1560, and ashaft of pitch track screw 1560 extends through spacer 1570 and threadsinto the female threaded holes of protrusions 1555-1 and 1555-2 on theforward surface of each arm of pitch screw yoke 1515. Collar 1565 andthe head of pitch track screw 1560 extends into pitch adjustment tracks1555-1 and 1555-2 of shell frame plate 1520.

As further shown in the box in the lower right corner of FIG. 15C,turning pitch adjustment screw 1500 in a CW direction (identified with a“1a”) causes screw 1500 to “screw” into pitch adjustment block 1505, inturn, causing shell frame plate 1520 and shell frame 1410 (not shown) tomove upwards such that the collar 1565 and the head of pitch track screw1560 of each assembly 1525-1 and 1525-2 slides downwards (identifiedwith a “1b”) within pitch adjustment tracks 1555-1 and 1555-2 of shellframe plate 1520. As also shown in FIG. 15C, turning pitch adjustmentscrew 1500 in a CCW direction (identified with a “2a”) causes screw 1500to “screw” out of pitch adjustment block 1505, in turn, causing shellframe plate 1520 and shell frame 1410 (not shown) to move downwards suchthat the collar 1565 and the head of pitch track screw 1560 of eachassembly 1525-1 and 1525-2 slides upwards (identified with a “2b”)within pitch adjustment tracks 1555-1 and 1555-2 of shell frame plate1520.

FIGS. 16A and 16B illustrate interconnection of shell frame plate 1520with shell frame 1410. As shown in FIG. 16A, block-to-plate attachmentscrew 1535 extends through shell frame plate 1520 and through shellframe 1410 into pitch adjustment block 1505 (not shown), andblock-to-shell attachment screw 1530 extends through shell frame 1410into pitch adjustment block 1505. FIG. 16B shows the underside of shellframe plate 1520 through a transparent shell frame 1410. Plate positionretention pin 1540 extends into a hole in shell frame 1410 to hold shellframe plate 1520 in position upon an inner surface of shell frame 1410.The screw head and the collar of pitch track screw assembly 1525-1slides upwards or downwards within pitch adjustment track 1555-1, whilethe shank of the screw of assembly 1525-1 extends through a pitchadjustment slot 1600-1 that extends through shell frame 1410. Further,the screw head and collar of pitch track screw assembly 1525-2 slidesupwards or downwards within pitch adjustment track 1555-2, while theshank of the screw of assembly 1525-2 extends through a pitch adjustmentslot 1600-2 that extends through shell frame 1410. Block-to-plateattachment screw 1535 is shown in FIG. 16B extending through a hole inshell frame plate 1520 and shell frame 1410. Block-to-shell frameattachment screw 1530 is shown extending through a hole in shell frame1410.

FIGS. 17A and 17B illustrate the interconnection of pitch adjustmentmechanism 1415 with support base 1405. Protrusion 1555-1 of pitch screwyoke 1515 extends through a hole 1710-1 in support base 1405, andprotrusion 1555-2 of pitch screw yoke 1515 extends through a hole 1710-1in support base 1405. A support base pitch adjustment slot 1700 extendsthrough pitch shell ramp 1425 to enable block-to-plate attachment screw1535 and block-to-shell frame attachment screw 1530 (not shown) toconnect pitch adjustment block 1505 to shell frame 1410 and to shellframe plate 1520.

FIGS. 18-20 illustrate adjustment of the pitch of shell frame 1410relative to support base 1405 using pitch adjustment mechanism 1415.FIG. 18 depicts a cut-away view of support base 1405, shell frame 1410,and pitch adjustment mechanism 1415 and their interaction duringadjustment of the pitch of shell frame 1410. Assuming a RH thread of thethreads on the shank 1800 of pitch adjustment screw 1500, when screw1500 is turned in a CW direction (identified with a “1” in FIG. 18), theshank 1800 of screw 1500 screws into pitch adjustment block 1505 causingpitch adjustment block 1505 to move upwards towards pitch screw yoke1515. As pitch adjustment block 1505 moves upwards, screws 1535 and1530, which extend through support base pitch adjustment slot 1700,slide through slot 1700 in an upwards direction pulling shell frame 1410in a same upwards direction. FIG. 19 illustrates a side view of bodypart immobilization device 1400 showing the upwards adjustment of pitchof shell frame 1410 as pitch adjustment screw 1500 is turned in a CWdirection. As shown in FIG. 19, the lower surface (i.e., pitch foot1440) of the front of shell frame 1410 slidably moves up pitch shellramp 1425 of support base 1405, and the lower surface (i.e., pitch foot1440) of the rear of shell frame 1410 slidably moves down pitch shellramp 1430. If shell frame 1410 is configured to immobilize a patient'shead, then adjusting the pitch of shell frame 1410 as shown in FIG. 19raises the patient's forehead relative to the patient's chin.

Returning to FIG. 18, assuming a RH thread of the threads on the shank1800 of pitch adjustment screw 1500, when screw 1500 is turned in a CCWdirection (identified with a “2” in FIG. 18), the shank 1800 of screw1500 screws out of pitch adjustment block 1505 causing pitch adjustmentblock 1505 to move downwards away from pitch screw yoke 1515. As pitchadjustment block 1505 moves downwards, screws 1535 and 1530, whichextend through support base pitch adjustment slot 1700, slide throughslot 1700 in a downwards direction pushing shell frame 1410 in a samedownwards direction. FIG. 20 illustrates a side view of body partimmobilization device 1400 showing the downwards adjustment of the pitchof shell frame 1410 as pitch adjustment screw 1500 is turned in a CCWdirection. As shown in FIG. 20, the lower surface (i.e., pitch foot1440) of the front of shell frame 1410 slidably moves down pitch shellramp 1425 of support base 1405, and the lower surface (i.e., pitch foot1440) of the rear of shell frame 1410 slidably moves up pitch shell ramp1430. If shell frame 1410 is configured to immobilize a patient's head,then adjusting the pitch of shell frame 1410 as shown in FIG. 10 lowersthe patient's forehead relative to the patient's chin.

FIGS. 14-20 depict an exemplary embodiment of body part immobilizationdevice 1400 that includes a screw-type pitch adjustment mechanism 1415which is not described as including a roll adjustment mechanism. Inother embodiments, however, body part immobilization device 1400 mayadditionally include a roll adjustment mechanism (and associatedstructure), such as that described with respect to FIGS. 7-13B above.

The foregoing description of implementations provides illustration anddescription, but is not intended to be exhaustive or to limit theinvention to the precise form disclosed. Modifications and variationsare possible in light of the above teachings or may be acquired frompractice of the invention. Although the invention has been described indetail above, it is expressly understood that it will be apparent topersons skilled in the relevant art that the invention may be modifiedwithout departing from the spirit of the invention. Various changes ofform, design, or arrangement may be made to the invention withoutdeparting from the spirit and scope of the invention. Therefore, theabove-mentioned description is to be considered exemplary, rather thanlimiting, and the true scope of the invention is that defined in thefollowing claims. For example, support base 120 or 1405 is shown anddescribed above as having a certain structure that allows shell frame130 or 1410 or shell frame carriage 710 to ride upon support base 120 or1405. In other implementations, however, support base 120 or 1405 mayinclude a different type of supporting structure, such as a base plateor a couch top, having a physical configuration that also enables shellframe 130 or 1410 or shell frame carriage 710 to ride upon the supportbase. In such implementations, the different types of supportingstructure may include a matching hole pattern for adjustment pinssimilar to that shown in FIGS. 3A-3D or FIG. 8A.

No element, act, or instruction used in the description of the presentapplication should be construed as critical or essential to theinvention unless explicitly described as such. Also, as used herein, thearticle “a” is intended to include one or more items. Further, thephrase “based on” is intended to mean “based, at least in part, on”unless explicitly stated otherwise.

What is claimed is:
 1. A structure, comprising: a base comprising afirst ramp and an opposing, second ramp; and a shell frame having aninner surface, configured to a shape of a body part, and an outer convexsurface, wherein the outer convex surface of the shell frame rides upon,and moves relative to, upper surfaces of the first ramp and the secondramp to enable a pitch of the shell frame to be adjusted relative to thebase.
 2. The structure of claim 1, wherein the first ramp comprises afirst concave ramp and wherein the second ramp comprises a secondconcave ramp.
 3. The structure of claim 1, further comprising: a pitchadjustment mechanism that enables adjustment of the pitch of the shellframe relative to the base.
 4. The structure of claim 3, wherein thepitch adjustment mechanism includes one of a clamp-type mechanism or ascrew-type mechanism to enable the adjustment of the pitch of the shellframe relative to the base.
 5. The structure of claim 3, wherein thepitch adjustment mechanism comprises: an adjustment fastener thatextends through the base and through the shell frame, a locking spacer,and an adjustment knob, wherein the adjustment knob connects to theadjustment fastener, and wherein the adjustment knob is rotatable tocause the locking spacer to tighten against a surface of the base toclamp the shell frame in a specific pitch position.
 6. The structure ofclaim 3, wherein the pitch adjustment mechanism further comprises apitch adjustment wheel, having a plurality of adjustment positions,wherein the pitch adjustment wheel is rotatable to the plurality ofadjustment positions to adjust the pitch of the shell frame to acalibrated pitch position.
 7. The structure of claim 3, wherein the baseincludes a pitch adjustment slot, and wherein the shell frame furthercomprises a movable frame coupled to the upper surfaces of the firstramp and the second ramp of the base, and the pitch adjustment mechanismfurther comprises: an adjustment fastener having a length configured toextend through the pitch adjustment slot and to couple with the movableframe; a locking spacer configured to receive the adjustment fastenerand to reside adjacent a lower surface of the base; and an adjustmentknob configured to attach to the adjustment fastener and to enableadjustment of a pitch of the movable frame relative to the base viamovement of the adjustment fastener within the pitch adjustment slot ofthe base.
 8. The structure of claim 7, wherein the adjustment knobattaches to the adjustment fastener by a pin that extends through theadjustment knob and through the adjustment fastener.
 9. The structure ofclaim 7, wherein a bottom of the movable frame resides on the first rampand the second ramp, and wherein movement of the adjustment fastenerwithin the pitch adjustment slot of the base causes the movable frame tomove either up the first ramp and down the second ramp, or down thefirst ramp and up the second ramp, to adjust the pitch of the movableframe relative to the base.
 10. The structure of claim 3, wherein thepitch adjustment mechanism comprises: a pitch adjustment block thatconnects to the shell frame; and a pitch adjustment screw that screwsinto, or out of, the pitch adjustment block to cause the adjustment ofthe pitch of the shell frame relative to the base.
 11. The structure ofclaim 10, wherein the pitch adjustment mechanism further comprises: apitch screw yoke that couples to the pitch adjustment screw; and a platethat connects to an inner surface of the shell frame and to the pitchadjustment block, wherein the plate includes pitch adjustment tracks onan underside of the plate and wherein the pitch screw yoke couples tothe pitch adjustment tracks and slidably moves within the pitchadjustment tracks based on movement of the pitch adjustment screw. 12.The structure of claim 1, wherein the shell frame comprises anapproximate half shell shape having a cut-out portion configured toreceive the body part.
 13. A structure, comprising: a support baseconfigured to be positioned on a flat surface and comprising a firstramp and a second, opposing ramp, wherein the first ramp and the secondramp each include upper surfaces upon which a movable frame rides toadjust a pitch of the movable frame relative to the support base. 14.The structure of claim 13, wherein the first ramp includes a firstconcave upper surface and the second ramp includes a second concaveupper surface and wherein the movable frame slidably moves against thefirst concave upper surface and the second concave upper surface toadjust the pitch of the movable frame relative to the support base. 15.The structure of claim 14, wherein a bottom of the movable frame resideson the first concave upper surface and the second concave upper surfaceand wherein adjustment of the pitch of the movable frame relative to thesupport base includes movement of the bottom of the movable frame up thefirst concave upper surface and down the second concave upper surface ormovement of the bottom of the movable frame down the first concave uppersurface and up the second concave upper surface.
 16. The structure ofclaim 13, further comprising: a pitch adjustment mechanism that enablesadjustment of the pitch of the movable frame relative to the supportbase.
 17. The structure of claim 16, wherein the pitch adjustmentmechanism includes one of a clamp-type mechanism or a screw-typemechanism that enables the adjustment of the pitch of the movable frame.18. The structure of claim 16, wherein the pitch adjustment mechanismfurther comprises a pitch adjustment wheel having adjustment teeth thatextend through a hole in the support base to engage with adjustmentnotches in a lower surface of the movable frame and wherein rotation ofthe pitch adjustment wheel causes the adjustment teeth to engage withthe adjustment notches and to move the movable frame relative to thesupport base causing a change in pitch of the movable frame.
 19. Thestructure of claim 13, further comprising: the movable frame, whereinthe movable frame has a shape that approximates half of athree-dimensional spheroid.
 20. A structure, comprising: a shell framehaving an inner surface, configured to a shape of a body part, and anouter convex surface that includes a pitch foot, wherein the pitch footof the shell frame is configured to ride upon, and move relative to,upper surfaces of a first ramp and a second ramp of a support base toenable a pitch of the shell frame to be adjusted relative to the supportbase.